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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1301-4301 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale).
Participants will participate in this study for 24 weeks. The study does not include any study medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consent video | Participants watching a pre-recorded consent video. |
| |
| Video call | Participants obtaining the information regarding the study at a video call from the study staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion of the electronic informed consent process (e-consent) | Count | Week -2 to week 0 |
| Body weight measurements recorded | Count | From week 0 (device set-up date) to the week 24 (end of study) |
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Inclusion Criteria:
Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
Willingness to consent via the e-consent process before any study-related activities (study- related activities are any procedure related to recording of data according to the protocol)
Male or female, age above or equal to 18 years at the time of signing informed consent
Body mass index (BMI) above or equal to 25 kg/m^2 self-reported in the Confirmation of Eligibility Questionnaire
About to initiate/has initiated at least one of the following weight management program(s) :
Willingness to follow study procedures
Willingness to, and capable of using the study devices and app
Fluent in oral and written Danish language
In possession of a compatible smartphone (minimum Android 10 and iOS14) throughout the study that has a reliable internet connection, regular connection to 4G/5G network, or Wi-Fi and that has the capability of downloading the study app and connecting with the smartwatch, the body composition scale and the data hub)
Exclusion Criteria:
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Participants with an overweight condition or obesity undergoing weight management prescribed by a general practitioner
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital, Steno Diabetes Center Aarhus | Aarhus | 8200 | Denmark |
According to the Novo Nordisk committment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |